And now there is a new wrinkle with the recent charge by a Texas Republican Congressman that the US Food and Drug Administration (FDA) may not have used all of the post marketing tools and data available when it addressed the potential for tainted heparin as the cause for patient fatalities.
Representative Joe Barton is a ranking member of the House Energy and Commerce Committee and wants the Government Accountability Office (GAO) to investigate how the FDA handled its investigation."This review should include addressing apparent discrepancies and gaps in FDA's assessment of heparin deaths that have been brought to my attention by minority committee staff," he says.
First on Barton's list of criticisms is the fact that the FDA did not immediately inspect the manufacturing facility in China, Changzhou SPL, once the contamination was discovered. He did not mention the fact that the FDA also admits failing to inspect the plant before giving its approval for the manufacture of heparin. The FDA has since indicated that the oversight was prompted by some kind of mix-up.
In contrast Baxter, the company manufacturing the largest volumes of heparin from the tainted raw heparin discovered at Changzhou, not only ceased production of heparin and recalled all lots of the tainted product, it also required the FDA to identify the MedWatch reports. Baxter then, independently investigated the cases, did site visits to hospitals and reviewed the respective medical records.
Baxter concluded that the 3 cases initially linked to the contamination were not caused by tainted heparin.
Barton is asking the GAO to investigate.
The federal drug agency indicated back in April that a "solid mechanistic link" between the contaminant originating in China and serious adverse events and deaths was found using in vitro and animal data.
The FDA sent correspondence dated Oct. 23 to Barton, detailing adverse event reports submitted from Jan. 1, 2007 to May 31, 2008. Of the 167 reported deaths related to heparin, 16 listed the heparin lot number and cited deaths in case summaries. Of those, 5 were considered unlikely to be related to the heparin contamination, and just 1 was considered to have a probable link. Three were considered possible links.
In the Oct. 23 correspondence to Barton, the FDA says, "it is often not possible to tell in an individual case if there is a causal relationship between the drug and the medical event or death. Many patients have other serious conditions that could have caused the problem."
For his part, Congressman Barton tells the GAO that in one of two cases classified as possibly being linked to contaminated heparin, the pharmacist who submitted the MedWatch report indicated in the follow-up section of the report that the death was determined not to be due to heparin.
Barton cites many unanswered questions with regard to heparin deaths. The Congressman indentified one case involving tainted heparin made by American Pharmaceutical Partners (APP)—a case that his staff is still waiting on from the FDA. "Without the additional information on these death cases, a question is raised about whether FDA has confounding or conflicting information about heparin death cases that has not been made public.
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Cases from June 1st to September 22nd include 13 heparin deaths but were not included in the analysis by the FDA.
As the issue continues to be unraveled, patients can be forgiven for being wary over heparin contamination. Heparin injection, which helps to thin the blood and prevent clotting, is prevalent in many procedures. While most will vouch for the quality, and the safety of the heparin product currently in the supply chain, there have been pockets of concern around the country that give the patient pause to wonder about the product flowing through that heparin syringe, into their arm.